CEO Itescu needs to go, page-752

@Bazsa,

I think you're missing the core issue.

There was a positive signal in children that was not statistically significant. In other words the results seen in a small number of children cherry-picked from a larger study could have happened by chance alone, not rem-L efficacy. Yes, a problem with "potancy" in this particular illness is in question. Medication potency is generally required to achieve medication efficacy, no? Efficacy as defined by the FDA.

So, the issue to resolve is not children vs adults, it's RCT's vs no (or only 1 failed) RCT... in order to prove efficacy.

We've been told by the experts that for this disease it's not ethical to do RCTs in children. OK, let's accept that. The last I checked children are members of the same species and the disease has comparable pathophysiology in children and adults. So proving rem-L is efficacious in adults where RCT's CAN be ethically done would be an important foundation and a start to obtaining a label extension to children... rather than going about it backwards without benefit of RCT's. 

The veracity of that analysis is supported by SI's August 4 PR.  To obtain approval for children he's now going to test adults.... rather than stubbornly pursuing children like he's been doing.  Concerned shareholders can reasonably pose this head-scratcher:

Why oh why didn't he do that starting years ago??  

imho, Left-e